MalfunctionFWY
OPERON
Received Oct 26, 2012 · Event occurred Sep 11, 2012
Report 8010153-2012-00010 · MDR key 2843876
Device
Product problems
- Device Operates Differently Than Expected
- Unintended Movement
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
PRIOR TO A SURGICAL PROCEDURE WITH NO PATIENT ON THE TABLE, THE TABLE WAS REPORTED TO BE MOVING INTO TILT WITH NO ACTIVATION OF THE HAND CONTROL.
Additional Manufacturer Narrative
THE TABLE WAS EVALUATED BY A BERCHTOLD FIELD SERVICE REPRESENTATIVE ON (B)(4) 2012. THE PROBLEMS COULD NOT BE DUPLICATED WHEN USING THE ORIGINAL HAND CONTROL, THE REPLACEMENT HAND CONTROL, AND THE SERVICE PROGRAM. THE ORIGINAL HAND CONTROL EXHIBITED SIGNS OF DAMAGE AND WAS REPLACED.